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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2206 with Stelara® in Patients with Moderate to Severe Plaque Psoriasis

    Summary
    EudraCT number
    		 2020-004504-33
    Trial protocol
    		 BG  
    Global end of trial date
    07 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jun 2024
    First version publication date
    06 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAT-2206-002-CR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04728360
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 China IND: CXSL1900103
    Sponsors
    Sponsor organisation name
    Bio-Thera Solutions, Ltd.
    Sponsor organisation address
    Floor 5, Building A6, 11 Kai-Yuan Blvd, Huangpu District, Guangzhou, China, 510530
    Public contact
    XiaoGe Jia, Bio-Thera Solutions, Ltd., +86 17665187738, xgjia@bio-thera.com
    Scientific contact
    XiaoGe Jia, Bio-Thera Solutions, Ltd., +86 17665187738, xgjia@bio-thera.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to demonstrate equivalent efficacy of BAT2206 and Stelara in patients with moderate to severe psoriasis.
    Protection of trial subjects
    This study was conducted in accordance with the accepted version of the Declaration of Helsinki in compliance with ICH GCP guidelines, and according to the appropriate regulatory requirements in the countries where the study was conducted. The clinical study protocol, protocol amendments, informed consent forms (ICFs), and any other appropriate study-related documents were reviewed and approved by independent ethics committees(IECs) and institutional review boards (IRBs) for each study center. Before entering the study, the investigator (or designee) explained to each subject (or their legally acceptable representatives, if applicable) the nature of the study, its purpose, procedures, expected duration, alternative therapy available, and the benefits and risks involved in study participation. Subjects were given written information about the study, and, before any study procedures were performed, each subject voluntarily signed and dated the ICF.
    Background therapy
    		 NA
    Evidence for comparator
    		 Ustekinumab belongs to the pharmacologic class of interleukin (IL)-23 and IL-12 antagonists. In the United States and the European Union, the approved indications include the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis.
    Actual start date of recruitment
    22 Jun 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 187
    Country: Number of subjects enrolled
    Georgia: 58
    Country: Number of subjects enrolled
    Russian Federation: 54
    Country: Number of subjects enrolled
    Poland: 184
    Country: Number of subjects enrolled
    Bulgaria: 73
    Worldwide total number of subjects
    556
    EEA total number of subjects
    257
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    521
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 41 investigators at 41 sites in 5 countries (China, Poland, Bulgaria, Russia, and Georgia) received IEC approval to participate in this study. 187 subjects were from China, 184 subjects were from Poland, 54 subjects were from Russia, 58 subjects were from Georgia, and 73 subjects were from Bulgaria.

    Pre-assignment
    Screening details
    		 Subjects with moderate to severe plaque-type psoriasis were screened in this study. A total of 773 subjects were screened and 556 subjects were randomized. Investigators completed the protocol defined screening procedures during ≤28-day screening period.

    Period 1
    Period 1 title
    Overall study （overall period ）
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    the investigators, site staff assessing the safety and efficacy, other related study staff (including contract research organization and sponsor), all subjects, and central laboratories would remain blinded to the study treatment assignment throughout this study. The unblinded site staff who were involved in study treatment administration and also were responsible for preparing the injection.The treatment assignment was not disclosed to any blinded personnel during study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BAT2206 Group
    Arm description
    		 Participants received SC injection of BAT2206, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16. At Week 28, participants with an improvement in PASI score of ≥75% were re-randomized to receive BAT2206 at Weeks 28 and 40.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAT2206
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of BAT2206, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16. At Week 28, participants with an improvement in PASI score of ≥75% were re-randomized to receive BAT2206 at Weeks 28 and 40.

    Arm title
    		 Stelara Group
    Arm description
    		 Participants received SC injection of ustekinumab, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16.At Week 28, participants with an improvement in PASI score of ≥75% were re-randomized to continue receiving ustekinumab , or to receive BAT2206 at Weeks 28 and 40.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Stelara
    Investigational medicinal product code
    Other name
    ustekinumab
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of ustekinumab, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16. At Week 28, participants with an improvement in PASI score of ≥75% were re-randomized to continue receiving ustekinumab , or to receive BAT2206 at Weeks 28 and 40.

    Number of subjects in period 1
    		BAT2206 Group Stelara Group
    Started
    278
    278
    Completed
    259
    256
    Not completed
    19
    22
         Consent withdrawn by subject
    5
    10
         Protocol specified withdrawal criterion met
    4
    2
         Adverse event, non-fatal
    1
    1
         Pregnancy
    -
    1
         Lost to follow-up
    4
    3
         Lack of efficacy
    1
    -
         other reason
    4
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BAT2206 Group
    Reporting group description
    		 Participants received SC injection of BAT2206, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16. At Week 28, participants with an improvement in PASI score of ≥75% were re-randomized to receive BAT2206 at Weeks 28 and 40.

    Reporting group title
    Stelara Group
    Reporting group description
    		 Participants received SC injection of ustekinumab, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16.At Week 28, participants with an improvement in PASI score of ≥75% were re-randomized to continue receiving ustekinumab , or to receive BAT2206 at Weeks 28 and 40.

    Reporting group values
    		 BAT2206 Group Stelara Group Total
    Number of subjects
    		 278 278 556
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 262 259 521
        From 65-84 years
    		 16 19 35
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 96 86 182
        Male
    		 182 192 374
    Region
    Units: Subjects
        Central Europe
    		 184 185 369
        Asia Pacific
    		 94 93 187
    Race
    Units: Subjects
        White
    		 183 185 368
        Asian
    		 95 93 188
    PASI Score
    The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale [0 = clear; 1-4 = increasing severity]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.
    Units: Score on a scale
        median (full range (min-max))
    		 21.20 (12.0 to 66.0) 22.3 (12.0 to 65.0) -
    sPGA
    The sPGA（Static Physician Global Assessment of Psoriasis）is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response was defined as a sPGA value of clear (score 0) or almost clear (score 1). Higher scores represent worse symptom severity.
    Units: Score on a scale
        median (full range (min-max))
    		 3.0 (3 to 5) 3.0 (3 to 5) -
    Psoriasis Body Surface Area (BSA)
    The percentage of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represents roughly 1% of the body's surface.
    Units: Percentage of BSA
        median (full range (min-max))
    		 26.00 (10.0 to 85.5) 29.00 (10.0 to 86.0) -
    DLQI
    The DLQI is a simple, self-administered questionnaire designed to measure the health-related quality of life of an adult suffering from a skin disease. It consists of 10 questions (each scored from 0 to 3) concerning patients’ perception of the impact of skin disease on different aspects of their health-related quality of life over the last week.
    Units: Score on a scale
        median (full range (min-max))
    		 15 (0 to 30) 14 (1 to 30) -

    End points

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    End points reporting groups
    Reporting group title
    BAT2206 Group
    Reporting group description
    		 Participants received SC injection of BAT2206, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16. At Week 28, participants with an improvement in PASI score of ≥75% were re-randomized to receive BAT2206 at Weeks 28 and 40.

    Reporting group title
    Stelara Group
    Reporting group description
    		 Participants received SC injection of ustekinumab, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16.At Week 28, participants with an improvement in PASI score of ≥75% were re-randomized to continue receiving ustekinumab , or to receive BAT2206 at Weeks 28 and 40.

    Subject analysis set title
    Through week28： BAT2206
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received SC injection of BAT2206, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16.

    Subject analysis set title
    Through week28：Stelara
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received SC injection of ustekinumab, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16.

    Subject analysis set title
    Post week28 :Stelara /BAT2206
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received SC injection of ustekinumab, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16. participants with an improvement in PASI score of ≥75% at Week 28 , were re-randomized to receive BAT2206 at Weeks 28 and 40.

    Subject analysis set title
    Post week28 :Stelara /Stelara
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received SC injection of ustekinumab, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16. participants with an improvement in PASI score of ≥75% at Week 28 , were re-randomized to continue receiving ustekinumab at week 28 and 40.

    Subject analysis set title
    Post week28 :BAT2206 /BAT2206
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received SC injection of BAT2206, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16. At Week 28, participants with an improvement in PASI score of ≥75% were re-randomized to continue receiving BAT2206 at Weeks 28 and 40.

    Primary: Percent change from baseline (CfB) in Psoriasis Area and Severity Index (PASI) score to Week 8

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    End point title
    		 Percent change from baseline (CfB) in Psoriasis Area and Severity Index (PASI) score to Week 8
    End point description
    PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration/thickness, and scaling) and percentage of affected skin surface area on defined anatomical regions.
    End point type
    Primary
    End point timeframe
    Baseline and Week8
    End point values
    		 BAT2206 Group Stelara Group
    Number of subjects analysed
    275
    274
    Units: Percent change in PASI Score
        least squares mean (standard error)
    -75.543 ( 2.6847 )
    -76.507 ( 2.6526 )
    Statistical analysis title
    		 Treatment Group :BAT2206 and Stelara
    Statistical analysis description
    Clinical equivalence of the primary endpoint was evaluated by comparing the 2-sided 90% confidence interval (CI) of the difference between treatments in mean %PASI CfB to Week 8 is entirely contained within the equivalence margin of [-13%, +13%] between BAT 2206 versus (vs) ustekinumab. Multiple imputation was applied for the point estimate and CI of the difference between treatments in mean %PASI CfB to Week 8 between the 2 groups.
    Comparison groups
    BAT2206 Group v Stelara Group
    Number of subjects included in analysis
    549
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.964
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.751
         upper limit
    		 4.679

    Primary: Percent change from baseline (CfB) in Psoriasis Area and Severity Index (PASI) score to Week 12

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    End point title
    		 Percent change from baseline (CfB) in Psoriasis Area and Severity Index (PASI) score to Week 12
    End point description
    PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration/thickness, and scaling) and percentage of affected skin surface area on defined anatomical regions.
    End point type
    Primary
    End point timeframe
    Baseline and week 12
    End point values
    		 BAT2206 Group Stelara Group
    Number of subjects analysed
    274
    275
    Units: Percent change in PASI score
        least squares mean (standard error)
    -85.039 ( 2.0731 )
    -86.813 ( 2.0105 )
    Statistical analysis title
    		 Treatment Group :BAT2206 and Stelara
    Statistical analysis description
    Clinical equivalence of the primary endpoint was evaluated by comparing the 2-sided 90% confidence interval (CI) of the difference between treatments in mean %PASI CfB to Week 12 is entirely contained within the equivalence margin of [-10%, +10%] between BAT 2206 versus (vs) ustekinumab. Multiple imputation was applied for the point estimate and CI of the difference between treatments in mean %PASI CfB to Week 12 between the 2 groups.
    Comparison groups
    BAT2206 Group v Stelara Group
    Number of subjects included in analysis
    549
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.774
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.679
         upper limit
    		 4.227

    Primary: Percent change from baseline (CfB) in Psoriasis Area and Severity Index (PASI) score to Week 12

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    End point title
    		 Percent change from baseline (CfB) in Psoriasis Area and Severity Index (PASI) score to Week 12
    End point description
    PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration/thickness, and scaling) and percentage of affected skin surface area on defined anatomical regions.
    End point type
    Primary
    End point timeframe
    Baseline and week12
    End point values
    		 BAT2206 Group Stelara Group
    Number of subjects analysed
    274
    275
    Units: Percent change in PASI score
        least squares mean (standard error)
    -85.039 ( 2.0731 )
    -86.813 ( 2.0105 )
    Statistical analysis title
    		 Treatment Group :BAT2206 and Stelara
    Statistical analysis description
    Clinical equivalence of the primary endpoint was evaluated by comparing the 2-sided 95% confidence interval (CI) of the difference between treatments in mean %PASI CfB to Week 12 is entirely contained within the equivalence margin of [-13%, +13%] between BAT 2206 versus (vs) ustekinumab. Multiple imputation was applied for the point estimate and CI of the difference between treatments in mean %PASI CfB to Week 12 between the 2 groups.
    Comparison groups
    BAT2206 Group v Stelara Group
    Number of subjects included in analysis
    549
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.774
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.149
         upper limit
    		 4.697

    Secondary: Percent change from baseline (CfB) in PASI at other timepoints

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    End point title
    		 Percent change from baseline (CfB) in PASI at other timepoints
    End point description
    PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration/thickness, and scaling) and percentage of affected skin surface area on defined anatomical regions.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 16, 20, 28
    End point values
    		 Through week28： BAT2206 Through week28：Stelara
    Number of subjects analysed
    278
    278
    Units: Percent change in PASI Score
    least squares mean (standard error)
        week 4
    -50.39 ( 3.011 )
    -49.80 ( 2.951 )
        week 16
    -86.38 ( 2.046 )
    -87.46 ( 2.012 )
        week 20
    -88.76 ( 1.849 )
    -89.56 ( 1.786 )
        week 28
    -90.54 ( 1.292 )
    -91.13 ( 1.265 )
    Statistical analysis title
    		 week 28 ：Group BAT2206 VS Group Stelara
    Comparison groups
    Through week28： BAT2206 v Through week28：Stelara
    Number of subjects included in analysis
    556
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.59
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 2.13

    Secondary: Proportion of patients who achieve at least 75% improvement from baseline in PASI at weeks 8, 12,16, 28, 40,52

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    End point title
    		 Proportion of patients who achieve at least 75% improvement from baseline in PASI at weeks 8, 12,16, 28, 40,52
    End point description
    End point type
    Secondary
    End point timeframe
    weeks 8, 12, 16,28, 40,52
    End point values
    		 Through week28： BAT2206 Through week28：Stelara Post week28 :Stelara /BAT2206 Post week28 :Stelara /Stelara Post week28 :BAT2206 /BAT2206
    Number of subjects analysed
    278
    278
    131
    133
    264
    Units: Proportion of Subjects
    number (not applicable)
        Week 8 (N = 275; 274; 0; 0; 0)
    54.66
    55.01
    0
    0
    0
        Week 12 (N = 274; 275; 0; 0; 0)
    76.32
    78.36
    0
    0
    0
        Week 16 (N = 275; 275; 0; 0; 0)
    83.54
    83.89
    0
    0
    0
        Week 28(N = 271; 269; 0; 0; 0)
    97.7
    98.09
    0
    0
    0
        Week 40 (N = 0; 0; 129; 132; 262)
    0
    0
    92.4
    94.7
    96.2
        Week 52 (N = 0; 0; 126; 128; 258)
    0
    0
    87.8
    91.7
    93.2
    Statistical analysis title
    		 Proportion of Subjects Achieving PASI-75% at W12
    Comparison groups
    Through week28： BAT2206 v Through week28：Stelara
    Number of subjects included in analysis
    556
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 % Estimated treatment difference
    Point estimate
    -2.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.99
         upper limit
    		 3.92

    Secondary: Proportion of Subjects With Static Physician’s Global Assessment Score on a 6-item Scale of Cleared (0) or Minimal (1) at weeks 8, 12,16,28

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    End point title
    		 Proportion of Subjects With Static Physician’s Global Assessment Score on a 6-item Scale of Cleared (0) or Minimal (1) at weeks 8, 12,16,28
    End point description
    The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity ofdisease (induration, scaling, and erythema). A sPGA response was defined as a sPGA value of clear(score 0) or almost clear (score 1). Higher scores represent worse symptom severity
    End point type
    Secondary
    End point timeframe
    week 8,12,16,28
    End point values
    		 Through week28： BAT2206 Through week28：Stelara
    Number of subjects analysed
    278
    278
    Units: Proportion of Subjects
    number (not applicable)
        Week 8(N = 269; 266)
    63.41
    59.55
        Week 12(N = 264; 264)
    80.08
    76.34
        Week 16(N = 271; 269)
    81.95
    85.85
        Week 28(N = 271; 268)
    89.46
    88.63
    No statistical analyses for this end point

    Secondary: AUEC for Psoriasis Area and Severity Index From Baseline at Weeks 8, 12, and 28

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    End point title
    		 AUEC for Psoriasis Area and Severity Index From Baseline at Weeks 8, 12, and 28
    End point description
    End point type
    Secondary
    End point timeframe
    week 8、12、28
    End point values
    		 Through week28： BAT2206 Through week28：Stelara
    Number of subjects analysed
    278
    278
    Units: Area Under the Effect Curve for PASI
    least squares mean (standard error)
        Week 8
    818.95 ( 44.969 )
    847.11 ( 44.112 )
        Week 12
    961.12 ( 57.052 )
    990.23 ( 56.007 )
        Week 28
    1294.80 ( 92.974 )
    1317.35 ( 91.115 )
    Statistical analysis title
    		 AUEC for PASI From Baseline at week 28
    Statistical analysis description
    AUEC ：Area Under the Effect Curve
    Comparison groups
    Through week28： BAT2206 v Through week28：Stelara
    Number of subjects included in analysis
    556
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -22.56
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -133.54
         upper limit
    		 88.43

    Secondary: Change From Baseline in Dermatology Life Quality Index Score at Weeks 8, 12, 28

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    End point title
    		 Change From Baseline in Dermatology Life Quality Index Score at Weeks 8, 12, 28
    End point description
    The DLQI is a simple, self-administered questionnaire designed to measure the health-related quality of life of an adult suffering from a skin disease. It consists of 10 questions (each scored from 0 to 3) concerning patients’ perception of the impact of skin disease on different aspects of their health-related quality of life over the last week.
    End point type
    Secondary
    End point timeframe
    Weeks 8,12, 28
    End point values
    		 Through week28： BAT2206 Through week28：Stelara
    Number of subjects analysed
    278
    278
    Units: Score
    arithmetic mean (standard deviation)
        Week 8 (N = 275; 274)
    -10.4 ( 6.85 )
    -9.4 ( 6.83 )
        Week 12 (N = 274; 275）
    -11.6 ( 7.12 )
    -11.1 ( 6.79 )
        Week 28 (N = 271; 269）
    -12.3 ( 7.22 )
    -11.9 ( 6.97 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Affected Body Surface Area at weeks 8, 12, 28

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    End point title
    		 Change From Baseline in Affected Body Surface Area at weeks 8, 12, 28
    End point description
    BSA is a measurement of the affected skin area. The overall BSA affected by psoriasis is estimated on the basis of the palm area of the patient’s hand (entire palmar surface or “handprint” including the fingers), which equates to approximately 1% of total BSA.
    End point type
    Secondary
    End point timeframe
    weeks 8,12,28
    End point values
    		 Through week28： BAT2206 Through week28：Stelara
    Number of subjects analysed
    278
    278
    Units: Score
    arithmetic mean (standard deviation)
        Week 8 (N = 275; 274)
    -18.43 ( 14.992 )
    -19.29 ( 15.083 )
        Week 12 (N = 274; 275)
    -23.04 ( 16.085 )
    -24.67 ( 15.290 )
        Week 28 (N = 271; 269)
    -28.29 ( 15.867 )
    -28.64 ( 14.740 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 (Week 0) to Week 28; Week 28 to Week 52
    Adverse event reporting additional description
    up to Week 28: Safety Analysis Set 1. Post Week 28: Safety Analysis Set 2
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Through week28 : BAT2206
    Reporting group description
    		 Participants received SC injection of BAT2206, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16.

    Reporting group title
    Through week28 : Stelara
    Reporting group description
    		 Participants received SC injection of ustekinumab, 45 mg (Baseline body weight <= 100 kg) or 90 mg Baseline body weight > 100 kg) at Weeks 0, 4, and week16.

    Reporting group title
    Post week28 :Stelara /BAT2206
    Reporting group description
    		 Participants received SC injection of ustekinumab, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16. participants with an improvement in PASI score of ≥75% at Week 28 , were re-randomized to receive BAT2206 at Weeks 28 and 40.

    Reporting group title
    Post week28 :Stelara /Stelara
    Reporting group description
    		 Participants received SC injection of ustekinumab, 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16. participants with an improvement in PASI score of ≥75% at Week 28 , were re-randomized to continue receiving ustekinumab at week 28 and week 40 .

    Reporting group title
    Post week28 :BAT2206 /BAT2206
    Reporting group description
    		 Participants received SC injection of BAT2206 , 45 mg (Baseline body weight <= 100 kg) or 90 mg (Baseline body weight > 100 kg) at Weeks 0, 4, and 16. participants with an improvement in PASI score of ≥75% at Week 28 , were re-randomized to continue receiving BAT2206 at week28 and week 40 .

    Serious adverse events
    		 Through week28 : BAT2206 Through week28 : Stelara Post week28 :Stelara /BAT2206 Post week28 :Stelara /Stelara Post week28 :BAT2206 /BAT2206
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 277 (1.81%)
    4 / 278 (1.44%)
    1 / 131 (0.76%)
    1 / 133 (0.75%)
    5 / 264 (1.89%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 278 (0.36%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polycythaemia vera
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 277 (0.00%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    1 / 133 (0.75%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Forearm fracture
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 278 (0.36%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord injury lumbar
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 277 (0.00%)
    0 / 278 (0.00%)
    1 / 131 (0.76%)
    0 / 133 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 277 (0.00%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 277 (0.00%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 277 (0.00%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 278 (0.36%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 277 (0.00%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 277 (0.00%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Interstitial lung disease
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 277 (0.00%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Epiglottitis
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 278 (0.36%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    0 / 264 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 277 (0.00%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    1 / 264 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Through week28 : BAT2206 Through week28 : Stelara Post week28 :Stelara /BAT2206 Post week28 :Stelara /Stelara Post week28 :BAT2206 /BAT2206
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    79 / 277 (28.52%)
    76 / 278 (27.34%)
    42 / 131 (32.06%)
    39 / 133 (29.32%)
    74 / 264 (28.03%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    7 / 277 (2.53%)
    10 / 278 (3.60%)
    5 / 131 (3.82%)
    2 / 133 (1.50%)
    5 / 264 (1.89%)
         occurrences all number
    7
    11
    5
    2
    5
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    5 / 277 (1.81%)
    6 / 278 (2.16%)
    3 / 131 (2.29%)
    2 / 133 (1.50%)
    1 / 264 (0.38%)
         occurrences all number
    5
    7
    3
    2
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 277 (2.17%)
    5 / 278 (1.80%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    0 / 264 (0.00%)
         occurrences all number
    6
    5
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 277 (0.00%)
    0 / 278 (0.00%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    6 / 264 (2.27%)
         occurrences all number
    0
    0
    0
    0
    6
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    0 / 277 (0.00%)
    0 / 278 (0.00%)
    2 / 131 (1.53%)
    4 / 133 (3.01%)
    3 / 264 (1.14%)
         occurrences all number
    0
    0
    2
    4
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 277 (1.44%)
    6 / 278 (2.16%)
    3 / 131 (2.29%)
    1 / 133 (0.75%)
    2 / 264 (0.76%)
         occurrences all number
    4
    6
    3
    1
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    17 / 277 (6.14%)
    20 / 278 (7.19%)
    21 / 131 (16.03%)
    21 / 133 (15.79%)
    39 / 264 (14.77%)
         occurrences all number
    17
    21
    21
    22
    39
    Upper respiratory tract infection
         subjects affected / exposed
    23 / 277 (8.30%)
    17 / 278 (6.12%)
    6 / 131 (4.58%)
    7 / 133 (5.26%)
    14 / 264 (5.30%)
         occurrences all number
    28
    21
    6
    9
    14
    Nasopharyngitis
         subjects affected / exposed
    12 / 277 (4.33%)
    9 / 278 (3.24%)
    1 / 131 (0.76%)
    2 / 133 (1.50%)
    10 / 264 (3.79%)
         occurrences all number
    14
    12
    1
    2
    12
    Urinary tract infection
         subjects affected / exposed
    6 / 277 (2.17%)
    3 / 278 (1.08%)
    1 / 131 (0.76%)
    3 / 133 (2.26%)
    3 / 264 (1.14%)
         occurrences all number
    6
    3
    1
    3
    3
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    7 / 277 (2.53%)
    9 / 278 (3.24%)
    3 / 131 (2.29%)
    3 / 133 (2.26%)
    5 / 264 (1.89%)
         occurrences all number
    8
    10
    3
    3
    5
    Hyperuricaemia
         subjects affected / exposed
    8 / 277 (2.89%)
    6 / 278 (2.16%)
    0 / 131 (0.00%)
    0 / 133 (0.00%)
    0 / 264 (0.00%)
         occurrences all number
    9
    6
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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